It is well established that patient compliance with medication dosing regimens is a major factors in the effectiveness of the underlying medications. (As used herein, the term “compliance”, when used in the context of a prescribed dosing regimen, is a neutral term which denotes not only the degree of conformance to the dosing regimen but also the degree of deviation from the dosing regimen. “Deviation”, on the other hand, in this same setting is used to denote the degree of disparity noted between the observed dosing pattern and the prescribed regimen.) For a medication to achieve its potential benefit, the proper number of doses of the medication must be taken and the spacing between doses needs to be correct. There are literally thousands of medical and scientific journal reports which describe the negative consequences of patient failures to properly adhere to prescribed dosing regimens. In some cases these consequences are relatively benign but in other cases compliance failures can actually cause the medication to do harm such as when antivirals and antibacterials are taken in a haphazard manner and the patient is not cured but instead medication-resistant strains emerge and increase the severity of the patient's infection.
It is understood in the pharmaceutical arts that recording the times at which medication doses are taken and analyzing the information so gathered can have two beneficial effects. It can give the health care professional a record of whether or not the doses of medication are being taken as prescribed. In addition, the presence of a record causes the patients to actually be more compliant with their prescribed medication regimens.
Aardex Ltd, and its associated company, Aprex Corporation, have for several years marketed medication containers having caps and other closures which monitor the removal of medication doses by ambulatory patients and create a record of the medication dosing events. Patents which describe various aspects of these devices include U.S. Pat. Nos. 4,939,705, 4,725,997, 4,971,221, 6,822,554 and 4,748,600.
While these monitors have proven to be reliable tools for enhancing patient compliance and maintaining a record of that compliance, it is now realized that monitoring devices with greater ability to adopt to a variety of different medications with differing pharmacodynamic properties would be advantageous. These differing pharmacodynamic properties among different drugs manifest themselves in differing degrees of sensitivity to deviations from prescribed regimens. Some drugs are relatively forgiving and exhibit only minor drop offs in effectiveness when the prescribed dosing pattern is poorly followed. Others have pharmacodynamic profiles which present major drop offs in effectiveness at the same degree of dosing deviation.
In addition, it has been taught that providing a monitor with the capability of communicating to the patient information about the prescribed dosing schedule and/or the patient's compliance to it can be beneficial in promoting compliance. However, it has been found that certain monitor-to-patient communications provide greater enhancements in compliance than others. It is desired to incorporate the ability to carry out such preferred communications into an improved monitor.